Inflatable medical implant system

ABSTRACT

A medical implant system for implantation in a patient to treat erectile dysfunction includes a first fluid path, an inflatable penile prosthesis cylinder, an electric pump, and implant controller, and an implantable power supply. The inflatable penile prosthesis cylinder is in fluid communication with the first fluid path and is configured for implantation in a corpus cavernosum of a patient. The electric pump is in fluid communication with the first fluid path. The implant controller is electrically coupled to the pump and is configured to activate the pump to drive a flow of fluid through the first fluid path and into the cylinder. The implantable power supply provides electrical power to the pump.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of, and claims priority to, U.S.patent application Ser. No. 15/851,204, filed on Dec. 21, 2017, entitled“INFLATABLE MEDICAL IMPLANT SYSTEM”, which is a Continuation of U.S.patent application Ser. No. 14/992,495, filed on Jan. 11, 2016, now U.S.Pat. No. 9,877,834, which is a Continuation of U.S. patent applicationSer. No. 14/062,991, filed on Oct. 25, 2013, now U.S. Pat. No.9,248,019, which is a continuation of U.S. patent application Ser. No.12/864,315, filed on Sep. 14, 2010, now U.S. Pat. No. 8,585,580, whichclaims priority of International Patent Application No.PCT/US2009/031669, filed on Jan. 22, 2009, published as WO 2009/094431on Jul. 30, 2009, and claims the benefit of U.S. Provisional PatentApplication No. 61/023,015, filed on Jan. 23, 2008, the content of eachof the above-referenced applications are incorporated herein byreference in their entirety.

FIELD OF THE INVENTION

Embodiments of the invention generally relate to implantable medicaldevices and, more specifically, to an inflatable implant systemcomprising an inflatable implant and an electric pump.

BACKGROUND

Common inflatable implants include prosthetic sphincters and penileprostheses. The inflatable sphincter typically includes an inflatablecuff that is placed around a duct of the patient. When the cuff isinflated, it constricts the duct and inhibits the flow of materialthrough the duct. Deflation of the cuff allows material to pass throughthe duct. Such artificial sphincters are often used to treat urinary andfecal incontinence. Inflatable penile prostheses typically include apair of inflatable cylinders which are implanted into the corpuscavernosae of the patient. The cylinders are inflated to produce thedesired penis rigidity for a normal erection and deflated to return thepenis to a flaccid state. Exemplary inflatable implant systems of theprior art utilizing an inflatable sphincter and inflatable penileprostheses are respectively described in U.S. Pat. No. 7,011,622 andU.S. Patent Application Publication No. 2006/0135845, both of which areincorporated herein by reference m their entirety.

FIG. 1 is a simplified diagram of an inflatable implant system 100 ofthe prior art that is commonly used with one or more inflatable implants102 in the form of an artificial sphincter or cuff, or penileprosthesis. The system 100 includes the inflatable implant 102, a manualpump 104 and a fluid reservoir 106. The inflatable implant 102 isimplanted in the patient in accordance with its designed application.The manual pump 104 is generally implanted in the scrotum of the patientand the reservoir 106 is implanted in the abdomen of the patient. Thedevice 100 forms a closed-loop system that can be filled with a suitablefluid, such as saline.

The inflatable implant 102 is in fluid communication with the pump 104through tubing 108, and the pump 104 is in fluid communication with thereservoir 106 through tubing 110. Fluid flows between the cuff 102 andthe reservoir 106 through the tubing 108, the tubing 110 and the pump104 to inflate and deflate the cuff 102.

The pump 104 includes a control assembly 112 for controlling the flow offluid to and from the cuff 102. The pump 104 is operated by manuallycompressing a pump chamber 114. The control assembly 112 can beconfigured to direct the fluid from the chamber 114 into the reservoir106 through the tubing 110 in response to the compression of the chamber114, which pressurizes the reservoir 106 and deflates the inflatableimplant 102. After the pressurization of the reservoir 106, the controlassembly 112 gradually releases fluid from the reservoir into theinflatable implant 102 to slowly re-inflate the implant 102. Thus, thefluid in the reservoir 106 is pressure-driven through the tubing 110,the control assembly 112, and the tubing 108, and into the inflatableimplant 102 to inflate the implant 102 until the pressures in thereservoir 106 and the inflatable implant 102 equalize. Thisconfiguration is typical for inflatable implants in the form ofartificial sphincters. The pressurized state of the reservoir 106 can bepreserved through the actuation of a button 115 of the control assembly112 by the patient.

The control assembly 112 can also be configured to direct the fluid fromthe chamber 114 into the inflatable implant 102 to inflate the implant102. This configuration is typical for inflatable implants in the formof penile prostheses. The pressurized state of the inflatable implant102 can be released through the actuation of the button 115 of thecontrol assembly 112 by the patient. This allows the fluid in theinflatable implant 102 to be pressure-driven through the tubing 108, thecontrol assembly 112, and the tubing 1110, and into the reservoir 106until the pressures in the reservoir 106 and the inflatable implant 102equalize.

The compression of the pump chamber 114 and actuation of the button 115for both the inflatable sphincter and penile prostheses forms of thesystem 100 require manual dexterity that some patients will not be ableto achieve. Accordingly, some patients who could benefit from the system100 are not suitable candidates for receiving it.

SUMMARY

Embodiments of the present invention are directed to a medical implantsystem for implantation in a patient to treat erectile dysfunction. Insome embodiments, the system comprises a first fluid path, an inflatablepenile prosthesis cylinder, an electric pump, and implant controller,and an implantable power supply. The inflatable penile prosthesiscylinder is in fluid communication with the first fluid path and isconfigured for implantation in a corpus cavernosum of a patient. Theelectric pump is in fluid communication with the first fluid path. Theimplant controller is electrically coupled to the pump and is configuredto activate the pump to drive a flow of fluid through the first fluidpath and into the cylinder. The implantable power supply provideselectrical power to the pump.

Other embodiments of the invention are directed to methods of operatingembodiments of the medical implant system to treat erectile dysfunction.In some embodiments of the method, an inflation command is wirelesslytransmitted to the implant controller using a state controller locatedexternally to the patient. The pump is activated using the implantcontroller responsive to the inflation command. Fluid is driven into thepenile prosthesis cylinder responsive to activating the pump.

Other features and benefits that characterize embodiments of the presentinvention will be apparent upon reading the following detaileddescription and review of the associated drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a simplified diagram of an inflatable implant system inaccordance with the prior art.

FIG. 2 is a simplified diagram of an inflatable medical implant systemin accordance with embodiments of the invention.

FIGS. 3 and 4 are simplified diagrams of a first configuration of theinflatable medical implant system in a filling state and an emptyingstate, respectively, in accordance with embodiments of the invention.

FIGS. 5 and 6 are simplified diagrams of a second configuration of theinflatable medical implant system in a filling state and an emptyingstate, respectively, in accordance with embodiments of the invention.

FIG. 7 is a simplified diagram of a state controller in accordance withembodiments of the invention.

FIG. 8 is a flowchart illustrating a method in accordance withembodiments of the invention.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Embodiments of the present invention are directed to an inflatablemedical implant system that can be implanted in a patient to treat acondition of the patient. FIG. 2 is a simplified diagram of aninflatable medical implant system 200 in accordance with embodiments ofthe invention. The system 200 includes an inflatable implant 202, anelectric pump 204 and a fluid reservoir 206. The system 200 is a closedloop system, in which a fluid, such as saline, flows between thereservoir 206 and the inflatable implant 202 to place the implant 202 ineither an inflated condition or a deflated condition in order to treatthe condition of the patient.

The inflatable implant 202 is configured to serve a medical purpose andrepresents one or more inflatable components that are configured forimplantation in a patient. The “medial purpose” of the implant 202 meansthat it is used to facilitate the treatment of a medical condition ofthe patient.

In one embodiment, the inflatable implant 202 comprises one ore moreartificial sphincters or cuffs that can each be implanted around a ductof the patient and control the flow of material through the duct of thepatient in order to treat a medical condition. The artificial sphincteror cuff inhibits the flow of material through the duct when inflated,and allows the flow of material through the duct when deflated. Suchartificial sphincters can be used to treat numerous medical conditions.For instance, the artificial sphincter can be placed around the urethraof the patient to treat urinary incontinence, the artificial sphinctercan be placed around the rectum or colon of the patient to treat fecalincontinence, the artificial sphincter can be used as a gastric cuff tocontrol weight loss dynamically, the artificial sphincter can be used asa stoma clamp/cuff in case of partial intestine or colon removal.Embodiments of the invention include the implantation of the system 200in a patient to treat at least one of the above-described conditions ina male or female patient.

In accordance with another embodiment, the inflatable implant 202 is inthe form of a penile prosthesis. As mentioned above, such an inflatableimplant 202 is implanted in one of the corpus cavernosa of the malepatient and is inflated to produce the desired penis rigidity of anormal erection and deflated to return the penis to a flaccid state.

The inflatable implant 202 can also take on other forms that can beimplanted in the patient and used to treat a medical condition of thepatient.

In one embodiment, the system 200 includes a first fluid path 208, asecond fluid path 210, and a third fluid path 212. The first fluid path208 fluidically couples the inflatable implant 202 to the pump 204. Thesecond fluid path 210 fluidically couples the inflatable implant 202 tothe reservoir 206. The third fluid path 212 fluidically couples the pump204 to the reservoir 206. The inflatable implant 202, the pump 204, thereservoir 206 and the fluid paths 208, 210 and 212, form a closed systemthat contains a fluid, such as saline.

Additional embodiments of the system 200 include a controller 216 and apower supply 218, such as an implantable battery. The power supply 218can supply power to the controller 216, the pump 204 and othercomponents of the system 200 that require electrical power, such asvalves. In one embodiment, the controller 216 operates to selectivelyactivate or deactivate the pump 204 in accordance with conventionaltechniques, to drive a flow of the fluid through the first fluid path208. As discussed in greater detail below, in accordance with someembodiments, the activation of the pump 204 drives the flow of fluid outof the inflatable implant 202 and through the first fluid path 208,while other embodiments drive the flow of fluid from the first fluidpath 208 into the inflatable implant 202. The control of the pump 204 bythe controller 216 can be accomplished in accordance with conventionalmethods. In one embodiment, the power supply 218 was electricallycoupled to the controller 216, which operates to selectively deliverelectrical power to activate the pump 204, or cut off power to the pump204 to deactivate the pump 204. Other suitable configurations can alsobe used.

One exemplary control electronic is a piezoelectric pump (e.g.,microdiaphragm pump), such as those supplied by ThinXXS including theMDP2205 microdiaphragm pump. The controller 216 also includes anynecessary control electronics, such as an electronic pump driver, whichmay be required due to cyclic voltage excursions at various frequenciesin accordance with the design of the pump 204.

Embodiments of the system 200 include one or more valves, such as valve221 in line with the first fluid path 208, valve 222 in line with thesecond fluid path 210, and valve 226 in line with the third fluid path212. The valves of the system 200 include any valve type that issuitable for performing the desired functions described below, such aslatching solenoid valves that are actuated through electrical controlsignals from the controller 216, check valves, and combinations thereof(e.g., one-way latching solenoid valves), for example. One suitablelatching solenoid valve that could be used is, for example, the series120 two-way solenoid valve produced by Lee Company. Embodiments of thevalves 221 and 226 also include valves that are integrated with the pump204.

Specific embodiments of the valves 221, 222 and/or 226 include valvesthat are actuated between an opened position, in which fluid is free totravel in the respective fluid path, and closed positions in which fluidis blocked from traveling in the respective fluid path. For instance,one embodiment of valve 221 can have an opened position, in which fluidis in which fluid is free to travel between the pump 204 and theinflatable implant 202 through the first fluid path 208, and a closedposition, in which fluid is blocked from traveling between the pump 204and the inflatable implant 202 through the first fluid path 208.Similarly, one embodiment of valve 222 has an opened position, in whichfluid is free to travel between the reservoir 206 and the inflatableimplant 202 through the second fluid path 210, and a closed position, inwhich fluid is blocked from traveling between the reservoir 206 and theinflatable implant 202 through the second fluid path 210. Also, oneembodiment of valve 226 has as an opened position, in which fluid isfree to travel between the reservoir 206 and the pump 204 through thethird fluid path 212, and a closed position, in which fluid is blockedfrom traveling between the reservoir 206 and the pump 204 through thethird fluid path 212. In one embodiment, two or more of the valves 221,222 and 226 are integrated into a single assembly.

In one embodiment, the controller 216 selectively actuates the valves221, 222 and/or 226 between opened and closed positions usingappropriate electrical control signals 227. In one embodiment thecontrol signals 227 from the controller 216 to one or more of the valves221, 222 and/or 226 comprise a short voltage pulse to switch the valvebetween the opened and closed positions. Such a short switching voltagepulse means that the valves do not have to be continuously energized,thus using little energy from the power supply 218 and prolonging thelife of the implantable power supply 218.

Embodiments of the system 200 include at least two configurations, eachcomprising a filling state, in which fluid is driven into the inflatableimplant 202 to inflate the implant 202, and an emptying state, in whichfluid is driven from the inflatable implant 202 to deflate the implant202. When the inflatable implant 202 is in the form of a cuff, theinflation of the cuff responsive to the filling state causes the cuff toconstrict the duct it surrounds to prevent the flow of material throughthe duct and prevent, for example, urinary incontinence. The deflationof the cuff responsive to the emptying state removes the constriction ofthe duct and allows material to flow through the duct to allow thepatient to urinate, for example. When the inflatable implant 202 is inthe form of a penile prosthesis, the inflation of the penile prosthesisresponsive to the filling state causes the penile prosthesis to expandthe corpus cavernosa to generate an erection, and the deflation of thepenile prosthesis responsive to the emptying state allows the corpuscavernosa to contract to place the penis in the flaccid state.

In a first configuration, the inflatable implant 202 is inflated withfluid by driving a flow of fluid from the reservoir 206, through thesecond fluid path 210 and into the inflatable implant 202 in response toa pressure difference between the fluid reservoir 206 and the inflatableimplant 202, and the system 200 deflates the inflatable implant 202 bydriving a flow of fluid from the inflatable implant 202 and into thefirst fluid path 208 using the pump 204. In accordance with a secondconfiguration, the system 200 inflates the inflatable implant 202 bydriving a flow of fluid from the first fluid path 208 into theinflatable implant 202, and the system 200 deflates the inflatableimplant 202 by driving a flow of fluid from the inflatable implant 202,through the second fluid path 210 and into the reservoir 206 in responseto a pressure difference between the inflatable implant 202 and thereservoir 206.

Embodiments of the filling and emptying states of the firstconfiguration will be respectively described with reference to thesimplified diagrams of the system 200 provided in FIGS. 3 and 4. In oneembodiment of the filling state, the pump 204 is deactivated and thevalve 222 is set to the opened position, in which fluid from thereservoir 206 is allowed to travel through the second fluid path 210 inthe direction of arrow 223 to the inflatable implant 202, as indicatedin FIG. 3. This flow of fluid is responsive to a pressure differencebetween the reservoir 206 and the inflatable implant 202. The flow offluid through the first fluid path is blocked by the valve 221 or 226while the system 200 is in the filling state. When the system ispressure balanced at the pressure of the reservoir 206 (i.e., systemquiescent state), the inflatable implant 202 reaches an inflated statehaving a desired inflated pressure or volume.

In one embodiment, at least one of the valves 221 or 226 has the openedand closed states described above. In FIG. 3, valve 226 is illustratedas being in the closed position during the filling state of the system200. In accordance with another embodiment, one or both of the valves221 and 226 are check valves that only allow fluid to flow in the firstand second fluid paths in the direction indicated by their arrows (FIG.4), respectively, when the pressure drop across the valves exceeds athreshold value that is greater than the desired maximum inflatedpressure of the implant 202. In one embodiment, the valve 222 does notcomprise a one-way check on the flow of fluid when in the openedposition, which would produce a significant pressure drop across thevalve 222. Thus, the opened position of the valve 222 substantiallyallows for unrestricted flow of fluid from the reservoir 206 to theinflatable implant 202 via the second fluid path 210. Such anunrestricted flow allows for faster filling of the inflatable implant202 and faster response to abdominal disturbances.

In the event of an abdominal disturbance in the patient that results inincreased abdominal pressure, the increased abdominal pressure acts onthe reservoir 206 to increase its internal pressure. In response to thispressure disturbance to the filling state of the system 200, additionalfluid is transferred from the reservoir 206 to the inflatable implant202 through the second fluid path 210, which increases the pressurewithin the inflatable implant 202 briefly to further expand theinflatable implant 202. When the duct is the urethra of the patient, anabdominal disturbance may increase the pressure on the bladder of thepatient. The abdominal disturbance will also cause a similar increase inpressure to the reservoir 206, which then drives fluid into theinflatable implant 202, which increases the pressure of the inflatableimplant 202. This increase in pressure of the inflatable implant 202further constricts the urethra and counters the additional push to theurine in the urethra caused by the increased pressure of the bladder. Asa result, incontinence caused by the abdominal disturbance can beprevented.

In one embodiment of the emptying state of the first configuration ofthe system 200, shown in FIG. 4, the valve 222 is set to the closedposition, the valve 226 is opened, and the pump 204 is activated todrive the flow of fluid from the implant in the direction indicated byarrows 225. More specifically, the pump 204 drives a flow of fluid fromthe inflatable implant 202 into the first fluid path 208, through thevalve 221, into the third fluid path 212, through the valve 226, andinto the reservoir 206. As a result, the inflatable implant 202 deflatesand the reservoir 206 inflates and becomes pressurized relative to theinflatable implant 202 to enable the refilling of the inflatable implant202 when the system returns to the filling state (FIG. 3).

One embodiment of the first configuration of system 200 includes anemptied state, in which the valve 222 is in the closed position and thepump 204 is deactivated. The system 200 is set in the emptied statefollowing the emptying state, in which the pressure of the inflatableimplant 202 is decreased to a desired deflated pressure or the volume ofthe inflatable implant 202 is decreased to a desired deflated volume.The system 200 can be placed in the emptied state for extended periodsof time because it does not require the use of electrical power from thesupply 218. When the inflatable implant 202 is in the form of a cuff,the resultant relaxation of the pressure on the duct from the inflatableimplant 202 can decrease tissue erosion of the duct.

Embodiments of the filling and emptying states of the secondconfiguration of the system 200 will be respectively described withreference to the simplified diagrams provided in FIGS. 5 and 6. In oneembodiment of the filling state shown in FIG. 5, the pump 204 isactivated and the valve 222 is set to the closed position, in whichfluid is blocked from traveling between the inflatable implant 202 andthe fluid reservoir 206 in the second fluid path 210. The pump 204drives the fluid from the reservoir 206 into the third fluid path 212and into the first fluid path 208 into the inflatable implant 202 asindicated by arrows 228. In one embodiment, the system 200 includes avalve 221, such as a check valve, that prevents the backflow of fluidtoward the pump 204. Accordingly, during the filling state, the fluidreservoir 206 is deflated of fluid while the inflatable implant 202 isinflated.

When the pump 204 is deactivated by the controller 216, the system 200enters an inflated or filled state where the inflatable implant 202 ismaintained at a desired inflated pressure or volume because the fluidwithin the inflatable implant is prevented from flowing back toward thepump through the first fluid path 208 due to the valve 221, and thefluid in the inflatable implant 202 is prevented from flowing to thefluid reservoir 206 through the second fluid path 210 due to the closedvalve 222.

In one embodiment of the emptying state of the second configuration ofthe system 200, shown in FIG. 6, the valve 222 is set to the openedposition, the pump 204 is deactivated and the valve 226 is actuated tothe closed position. A flow of fluid from the inflatable implant 202 isdriven in the direction indicated by arrow 229 into the second fluidpath 210, through the valve 222 and into the fluid reservoir 206 inresponse to a pressure difference between the inflatable implant 202 andthe fluid reservoir 206. Eventually, the flow of fluid through thesecond fluid path 210 stops when the pressures in the inflatable implant202 and the fluid reservoir 206 become balanced. In one embodiment, thevalve 222 is a check valve that prevents the backflow of fluid from thereservoir 206 to the implant 202. Accordingly, the implant can befurther deflated by squeezing the implant, which drives additional fluidfrom the implant 202, past the check valve 222 and into the reservoir206.

One embodiment of the second configuration of system 200 includes anemptied state, in which the valve 222 is in the closed position, thepump 204 is deactivated and the valves 226 or 221 are closed. The system200 is set in the emptied state following the emptying states, duringwhich the pressure of the inflatable implant 202 is decreased to adesired deflated pressure or the volume of the inflatable implant 202 isdecreased to a desired deflated volume. The system 200 can be placed inthe emptied state for extended periods of time because it does notrequire the use of electrical power from the supply 218.

In one embodiment, the controller is configured to control the valves,such as valves 221, 222, and/or 226, and the pump 204 to selectivelyplace the system 200 in the filling state, the emptying state or theemptied state. The controller 216 can be configured to transition thesystem 200 from the emptying state to the filling state, and transitionthe system 200 from the filling state to the emptying state, in variousways. In one embodiment, the controller 216 is configured to activatethe pump 204 for a set period of time while in the emptying state (FIG.4) of the first configuration of the system 200, and the filling state(FIG. 5) of the second configuration of the system 200. The run time forthe pump 204 for the emptying state (FIG. 4) and the filling state (FIG.5) can be adjusted in accordance with the size of the inflatable implant202 and the volumetric flow rate of the fluid flow driven by the pump204. In one embodiment of the first configuration of the system 200, thecontroller 216 automatically places the system 200 in the filling state(FIG. 3) after the system 200 has been in the emptying state (FIG. 4)for a predetermined period of time. In one embodiment of the secondconfiguration of the system 200, the controller 216 automatically placesthe system 200 in the filled state after the system 200 has been in thefilling state (FIG. 5) for a predetermined period of time.

Additional embodiments of the system 200 relate to the transitioning ofthe pump 204 from the activated state (FIGS. 4 and 5) to thecorresponding deactivated state (FIGS. 3 and 6) in response to apressure feedback signal that is indicative of the interior pressure ofthe inflatable implant 202, which is further indicative of whether theinflatable implant 202 has reached the desired inflated state ordeflated state. In one embodiment, the controller 216 deactivates thepump 204 when the pressure feedback signal indicates that the inflatableimplant 202 has reached the desired deflated state during the emptyingstate (FIG. 4) for the first configuration of the system 200, or thedesired inflated state during the inflating state (FIG. 5) for thesecond configuration of the system 200. In one embodiment, upondeactivating the pump 204, the first configuration of the system 200 isplaced in the deflated state, and the second configuration of the system200 is placed in the inflated state. Exemplary embodiments of thepressure feedback signal are described below.

In one embodiment, the system 200 comprises a pressure sensor 230, whichdirectly measures the interior pressure in the inflatable implant 202,or indirectly measures the interior pressure of the inflatable implant202 by sensing the pressure in the first fluid path 208, the secondfluid path 210 or the third fluid path 212, from which the pressure ofthe inflatable implant 202 can be estimated. The pressure sensor 230produces the pressure feedback signal 232 (FIG. 2) that is indicative ofthe sensed pressure and can be analyzed to determine whether theinflatable implant 202 has reached the desired deflated or inflatedstate.

In one embodiment, the controller 216 compares the sensed pressure valueindicated by the signal 232 to an empirically set threshold value thatcorresponds to the value indicated by the signal 232 when the inflatableimplant 202 is in the desired deflated or inflated state. Alternatively,the empirically set threshold can correspond to a maximum pressure thatthe inflatable implant 202 is desired to have. The controller 216deactivates the pump when the value indicated by the signal 232 reaches(e.g., exceeds) the threshold value.

In accordance with another embodiment, the controller 216 samples thesensed pressure value indicated by the signal 232 and compares thechange in the sensed pressure value over a predetermined period of timeto an empirically set threshold change in value, which corresponds tothe inflatable implant 202 reaching the desired deflated or inflatedstate. When the change in the sensed pressure value reaches (e.g.,exceeds) the threshold change in value, the controller deactivates thepump 204.

In accordance with another embodiment, the system 200 comprises acurrent sensor or voltage sensor, which are both represented by box 234in FIG. 2 in order to simplify the drawing. The current sensor measuresthe current drawn by the pump 204 during activation periods and producesan output signal 236 that is indicative of the magnitude of the sensedcurrent. The voltage sensor measures the voltage supplied to the pump204 during activation periods and produces an output signal 236 that isindicative of the magnitude of the sensed voltage.

When the inflatable implant 202 is substantially depleted of fluid(i.e., deflated state) or when the inflatable implant 202 issubstantially filled with fluid (i.e., inflated state), the currentdrawn by the pump will increase dramatically. Accordingly, the amount ofcurrent fed to the pump can be used to indicate the pressure of theinflatable implant 202 and whether the inflatable implant 202 hasreached the desired deflated state while the system 200 (firstconfiguration) is in the emptying state (FIG. 4), or whether theinflatable implant 202 has reached the desired inflated state while thesystem 200 (second configuration) is in the filling state (FIG. 5).Thus, the signal 236 from the current sensor 234 can operate as thepressure feedback signal.

In one embodiment, the controller 216 compares the sensed current valueindicated by the signal 236 to an empirically set threshold value, whichcorresponds to the inflatable implant 202 reaching the desired deflatedor inflated state. When the sensed current value reaches (e.g., exceeds)the threshold value, the controller 216 deactivates the pump 204.

In accordance with another embodiment, the controller 216 samples thesensed current value indicated by the signal 236 and compares the changein the sensed current value over a predetermined period of time to anempirically set threshold change in value, which corresponds to theinflatable implant 202 reaching the desired deflated or inflated state.When the change in the sensed current value reaches (e.g., exceeds) thethreshold change in value, the controller deactivates the pump 204.

It has also been recognized that the voltage supplied to the pump 204from the power supply 218 generally determines the maximum and minimumpressures that can be generated by the pump in the first fluid path and,thus, the inflatable implant 202 over a specified period of time. Thatis, the resultant pressure of the inflatable implant 202 from operatingthe pump 204 can be estimated by the voltage supplied to the pump 204and the length of the time that the pump 204 is activated. Thus, thesignal 236 from the voltage sensor 234 can operate as the pressurefeedback signal, from which interior pressure and state (i.e., desiredinflated or deflated state) of the inflatable implant 202 can beestimated. In one embodiment, upon activation of the pump 204, thecontroller 216 compares the sensed voltage value indicated by the signal236 to values stored in a loup table. The lookup table provides aruntime that the pump should be activated to reach the desired deflatedor inflated state. The controller 116 deactivates the pump uponexpiration of the runtime to place the inflatable implant 202 in thedesired deflated or inflated state.

One embodiment of the system 200 includes a state controller 240, shownin FIG. 2, that is configured to generate state commands, represented bysignal 242. In one embodiment, the controller 216 places the system 200in the filling state, the filled state, the emptying stated, or theemptied state, in response to the state commands 242.

FIG. 7 is a simplified diagram of the state controller 240 in accordancewith embodiments of the invention. In one embodiment, the statecontroller 240 is an external device, such as a key fob, that thepatient can use to place the system 200 in the desired state. In oneembodiment, the state commands 242 are transmitted wirelessly to thecontroller 216 in response to a user input. In one embodiment, thecontroller 216 performs a control function responsive to the receivedstate command 242. Exemplary control functions include activating thepump 204, deactivating the pump 204, actuating the valve 222 to theopened position using the electrical control signal 227, or actuatingthe valve 222 to the closed position using the control signal 227.

In accordance with another embodiment, the controller 216 places thesystem 200 in one of the filling, filled, emptying, or emptied states inresponse to the received state command 242. In one embodiment, the statecontroller 240 includes a “DEFLATE” button 244, which, when pressed bythe user, transmits a state command 242 to the controller 216 and thecontroller 216 places the system 200 in the emptying state (FIGS. 4 and6) in response to the received state command 242. In another embodiment,the state controller 240 includes an “INFLATE” button 246, which, whenpressed by the user, causes the state controller 240 to transmit a statecommand 242 to the controller 216 and the controller places the system200 in the filling state (FIGS. 3 AND 5) in response to the statecommand 242. Of course, the button 246 is unnecessary when thecontroller 216 is configured to set the system 200 in the filling stateautomatically following the expiration of a predetermined period of timeafter the placement of the system 200 in the emptying state.

In accordance with another embodiment, the state controller 240 includesa “SYSTEM OFF” button 248, which, when pressed by the user, transmits astate command 242 to the controller 216 and the controller 216 todeactivate the pump 204 and maintain the inflatable implant 202 in thecurrent deflated or inflated state by, for example, closing valve 222.Thus, the “SYSTEM OFF” button 248 can place the system 200 in the filledor emptied states.

In one embodiment, the state controller 240 is implanted in the patientat a location that is accessible by the patient, such as the scrotum ofa male patient. The state controller 240 communicates with thecontroller 216 either wirelessly or through a wired connection. In oneembodiment, the state controller 240 comprises one or more buttons thatthe patient can locate, and distinguish the individual buttons from theothers, by feel. In one embodiment, the state controller 240 comprises abutton, depressions of which cause the state controller 240 to cyclethrough two or more of the state commands (e.g., filling state, thefilled state, the emptying stated, or the emptied state) in a desiredorder, which are delivered to the controller 116 as signals 242. Thisallows the state controller to have only a single button while providingthe patient a full range of commands for the system 200.

Another embodiment of the invention is directed to a surgical kitcomprising the inflatable implant 202, the pump 204, the reservoir 206,the controller 216, and the power supply 218. In one embodiment, the kitfurther comprises valve 221, valve 222 and/or valve 226, each of whichmay be integrated with, or attached to, one of the other components ofthe system 200 provided in the kit, such as with the pump 204. In oneembodiment, the kit includes tubing to form the first fluid path 208,the second fluid path 210 and the third fluid path 212.

The components of the kit are preferably sterilized and sealed in acontainer, such as a bag. In one embodiment, the components of the kitare coated with an antibacterial coating, such as InhibiZone AntibioticSurface Treatment, a proprietary combination of rifampin andminocycline.

Yet another embodiment of the invention is directed to the methodillustrated in the flowchart of FIG. 8. At step 250 of the method, aninflatable medical implant system 200 (FIG. 2), in accordance with oneor more of the embodiments described above, is provided. In oneembodiment, step 250 comprises providing: an inflatable implant 202; apump 204; a reservoir 206; a first fluid path 208 between the inflatableimplant and the pump; a second fluid path 210 between the inflatableimplant and the reservoir; a third fluid path 212 between the reservoirand the pump; a valve 222 in the second fluid path having an openedposition, in which fluid is free to travel between the reservoir and theinflatable implant through the second fluid path, and a closed position,in which fluid is blocked from traveling between the reservoir and theinflatable implant through the second fluid path; a controller 216configured to control the pump and selectively actuate the valve betweenthe opened and closed positions; and an implantable power supply thatprovides electrical power to the pump. In one embodiment, the system 200is provided in the form of a surgical kit, as described above.

At step 252, of the method, the inflatable medical implant system 200 isimplanted in a male or female patient in accordance with conventionalsurgical techniques.

In one embodiment of the method, the system 200 is operated whileimplanted in the patient to treat a condition of the patient.Embodiments of this method step comprise inflating the inflatableimplant 202, as indicated at step 254, by either placing the valve 222in the opened position and driving a flow of fluid from the reservoir206 into the inflatable implant 202 through the second fluid path 210 inresponse to a pressure difference between the reservoir 206 and theinflatable implant 202, or placing the valve 222 in the closed positionand driving a flow of fluid from the first fluid path into theinflatable implant 202 using the pump 204. Another embodiment ofoperating of the system 200 while implanted in the patient comprisesdeflating the inflatable implant 202, as indicated at step 256, byeither placing the valve 222 in the closed position and driving a flowof fluid from inflatable implant 202 into the first fluid path 208 usingthe pump 204, or placing the valve 222 in the opened position anddriving a flow of fluid from the inflatable implant 202 into thereservoir 206 through the second fluid path 210 in response to apressure difference between the implant 202 and the reservoir 206. Inone embodiment, the medical condition of the patient is treated inresponse to the inflation the inflatable implant 202 and/or thedeflation the inflatable implant 202, as indicated at step 258.Embodiments of the medical condition include urinary incontinence andfecal incontinence.

In one embodiment of the method, a pressure feedback signal, such assignal 232 or 236 (FIG. 2), is generated in response to driving fluidthrough the first fluid path 208 using the pump 204. The pressurefeedback signal is in indicative of the pressure of the inflatableimplant 202. The pump 204 is deactivated using the controller 216 inresponse to the pressure feedback signal. In one embodiment, thepressure feedback signal 236 is generated responsive to a sensed currentby a current sensor 234. In one embodiment, the pressure feedback signal236 is generated responsive to a sensed voltage by a voltage sensor 234.In another embodiment, the pressure feedback signal 232 is generatedresponsive to a sensed pressure by a pressure sensor 230.

In one embodiment of the method, the inflatable implant comprises aninflatable cuff or an inflatable penile prosthesis. In one embodiment,the inflatable cuff is implanted around the urethra of the patient. Inanother embodiment, the inflatable cuff is implanted around the colon orrectum of the patient. In one embodiment, the inflatable cuff isimplanted for use as a gastric cuff to control weight loss dynamically.In one embodiment, the inflatable cuff is implanted for use as a stomaclamp/cuff on the intestine or colon of the patient where portions havebeen removed.

In accordance with the above discussion, one embodiment of the inventionis directed to a method comprising:

-   -   providing (250) an inflatable medical implant system (200)        comprising an inflatable implant (202); a pump (204); a        reservoir (206); a first fluid path (208) between the inflatable        implant and the pump; a second fluid path (210) between the        inflatable implant and the reservoir; a third fluid path (212)        between the reservoir and the pump; a valve (222) in the second        fluid path having an opened position, in which fluid is free to        travel between the reservoir and the inflatable implant through        the second fluid path, and a closed position, in which fluid is        blocked from traveling between the reservoir and the inflatable        implant through the second fluid path; a controller (216)        configured to control the pump and selectively actuate the valve        between the opened and closed positions; and an implantable        power supply (218) that provides electrical power to the pump;    -   implanting (252) the inflatable medical implant system in a        patient;    -   inflating (254) the inflatable implant comprising one of:        -   placing the valve in the opened position and driving a flow            of fluid from the reservoir into the inflatable implant            through the second fluid path in response to a pressure            difference between the reservoir and the inflatable implant;            and        -   placing the valve in the closed position and driving a flow            of fluid from the first fluid path into the inflatable            implant using the pump;    -   deflating (256) the inflatable implant comprising one of:        -   placing the valve in the closed position and driving a flow            of fluid from inflatable implant into the first fluid path            using the pump; and        -   placing the valve in the opened position and driving a flow            of fluid from the inflatable implant into the reservoir            through the second fluid path in response to a pressure            difference between the implant and the reservoir; and    -   treating (258) a medical condition of the patient in response to        at least one of inflating the inflatable implant and deflating        the inflatable implant.

In one embodiment, the method further comprises:

-   -   generating a pressure feedback signal (232 or 236) in response        to driving fluid through the first fluid path using the pump,        wherein the pressure feedback signal is indicative of a pressure        of the inflatable implant; and    -   deactivating the pump using the controller responsive to the        pressure feedback signal.

One embodiment of generating a pressure feedback signal comprises atleast one method step selected from the group consisting of:

-   -   sensing a current provided to the pump and generating the        pressure feedback signal (236) responsive to the sensed current;        and    -   sensing a voltage supplied to the pump and generating the        pressure feedback signal (236) responsive to the sensed voltage.

One embodiment of providing an inflatable medical implant systemcomprises providing an inflatable implant selected from the groupconsisting of an inflatable cuff and a penile prosthesis.

Although the present invention has been described with reference topreferred embodiments, workers skilled in the art will recognize thatchanges may be made in form and detail without departing from the spiritand scope of the invention.

What is claimed is:
 1. An apparatus comprising: an inflatable implanthaving a first portion and a second portion different than the firstportion; a fluid reservoir having a direct fluid connection to the firstportion of the inflatable implant via a first fluid path; a pumpfluidically coupled to the fluid reservoir via a second fluid path, thepump having a direct fluid connection to the second portion of theinflatable implant via a third fluid path; and a valve disposed withinthe second fluid path, wherein fluid is configured to flow from thefluid reservoir to the inflatable implant via the first fluid path whenthe apparatus is in a filling state and fluid is configured to flow fromthe inflatable implant to the pump via the third fluid path and from thepump to the fluid reservoir via the second fluid path when the apparatusis in an emptying state.
 2. The apparatus of claim 1, furthercomprising: a valve disposed within the first fluid path.
 3. Theapparatus of claim 1, further comprising: a first valve disposed withinthe first fluid path; and a second valve disposed within the secondfluid path.
 4. The apparatus of claim 1, further comprising: acontroller operatively coupled to the pump to selectively activate thepump.
 5. The apparatus of claim 1, further comprising: a controlleroperatively coupled to the pump; and a power supply operatively coupledto the controller.
 6. The apparatus of claim 1, further comprising: asensor configured to sense one of a current and a voltage supplied tothe pump and output a pressure feedback signal that is indicative of apressure of the inflatable implant.
 7. The apparatus of claim 1, whereinthe inflatable implant is selected from the group consisting of aninflatable cuff and a penile prosthesis.
 8. The apparatus of claim 1,wherein the first fluid path includes tubing, the second fluid pathincludes tubing, and the third fluid path includes tubing.
 9. Theapparatus of claim 1, further comprising: a pressure sensor operativelycoupled to the inflatable implant and configured to measure an internalpressure of the inflatable implant.
 10. An apparatus comprising: aninflatable implant having a first portion and a second portion differentthan the first portion; a fluid reservoir having a direct fluidconnection to the first portion of the inflatable implant via a firsttubing, the first tubing having a first end portion coupled to the fluidreservoir and a second end portion coupled to the inflatable implant;and a pump fluidically coupled to the fluid reservoir via a secondtubing, the second tubing having a first end portion coupled to the pumpand a second end portion coupled to the fluid reservoir, the pump havinga direct fluid connection to the second portion of the inflatableimplant via a third tubing, the third tubing having a first end portioncoupled to the pump and second end portion coupled to the inflatableimplant, wherein fluid is configured to flow from the fluid reservoir tothe inflatable implant via the first tubing when the apparatus is in afilling state and fluid is configured to flow from the inflatableimplant to the pump via the third tubing and from the pump to the fluidreservoir via the second tubing when the apparatus is in an emptyingstate.
 11. The apparatus of claim 10, further comprising: a valvedisposed within the first tubing.
 12. The apparatus of claim 10, furthercomprising: a valve disposed within the second tubing.
 13. The apparatusof claim 10, further comprising: a first valve disposed within the firsttubing and a second valve disposed within the second tubing.
 14. Theapparatus of claim 10, further comprising: a controller operativelycoupled to the pump to selectively activate the pump.
 15. The apparatusof claim 10, further comprising: a controller operatively coupled to thepump; and a power supply operatively coupled to the controller.
 16. Theapparatus of claim 10, further comprising: a sensor configured to senseone of a current and a voltage supplied to the pump and output apressure feedback signal that is indicative of atho pressure of theinflatable implant.
 17. The apparatus of claim 10, wherein theinflatable implant is selected from the group consisting of aninflatable cuff and a penile prosthesis.
 18. The apparatus of claim 10,further comprising: a pressure sensor operatively coupled to theinflatable implant and configured to measure an internal pressure of theinflatable implant.